Yesterday the US Supreme Court issued its much anticipated opinion in the Myriad case (Association for Molecular Pathology v. Myriad Genetics Inc., U.S., No. 12-398, 6/13/13). The Supreme Court had been asked to address a single question: “Are human genes patentable?” The patents at issue were three patents owned by Myriad on the BRCA1 and BRCA2 genes, mutations of which are associated with significantly increased risk of breast and /or ovarian cancer. The US Federal Circuit had found Myriad’s claims to isolated DNA and cDNA to be patent eligible, in contrast to the District Court.

The Supreme Court found that naturally occurring DNA segments are “products of nature”, and so are not patentable in the US, regardless of the amount of effort involved in discovering such sequences, even though these sequences had been isolated from the human body. This means that the long-standing US Patent Office practice of recognising the patent eligibility of genes will need to be changed.  It also contrasts with the European position, where there is no absolute bar on patenting genes which have been isolated from the human body if – which can be a significant challenge – the normal patent requirements of novelty, inventive step and industrial applicability are met.

The Supreme Court agreed with the Federal Court’s view that cDNA claims can be valid. The Supreme Court found that cDNA, i.e. synthetically created exon-only strands of nucleotide sequences, is not a “product of nature” because it is not naturally occurring, and so can be patent eligible.

As expected, the Supreme Court did not make any rulings in relation to broader patent eligibility issues such as claims for methods of interpreting genetic testing results, testing drug efficacy or manipulating genes. Nor did it comment on the patentability – or otherwise – of DNA in which scientists have altered the order of the naturally occurring nucleotides.

The Supreme Court’s decision not to ban the patenting of cDNA sequences will be a relief to many in the innovative life science industry on both sides of the Atlantic. Although naturally occurring gene sequences are no longer considered patentable, the trend for a number of years now has been to move away from drafting such claims, or at least not to rely exclusively on such claims, in favour of more complex patent claims involving non-native genetic constructs, and incorporating sequence changes to make the sequences appear less “natural”. The practical ramifications of this decision are unlikely therefore to be as far-reaching as many reports in the popular press would suggest.

The BIA’s Intellectual Property Advisory Committee is monitoring and assessing the likely impact of the Myriad decision on behalf of the membership.